DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 and 9-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 states the following limitations that have are not mentioned in the specification, claims, or drawings as originally filed: “using a single image acquisition protocol” (lines 3-4) and “wherein the risk assessment of coronary artery disease…..aortic disease……pneumonia, and…..pulmonary embolism are generated substantially concurrently from analyzing one or more portions of the one or more medical images obtained using the single image acquisition protocol”. There is no mention in the specification of these risk assessments being generated concurrently with each other in the originally filed application nor is there mention of taking all 4 from a single portion of an image (one or more portions) and it is unclear how all 4 of these can be determined by as single portion of an image. Further there is no mention of all 4 of the risk assessments being analyzed from a single image acquisition protocol.
Claim 21 states “accessing cardiac and pulmonary data” along with additional analyzing steps of the risk assessment and hospital admission and discharge using an artificial intelligence algorithm. The processing of this data is not mentioned in the specification as originally filed. Applicant is asked to provide the specific support for this new claim in the specification. Additionally there is no written description of said algorithm or what it entails to achieve the risk assessment.
Claims 2-7 and 9-21 depend from claim 1 and therefore inherit the 35 USC 112 deficiencies of their parent claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 and 9-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 states wherein the risk assessment of coronary artery disease…..aortic disease……pneumonia, and…..pulmonary embolism are generated substantially concurrently from analyzing one or more portions of the one or more medical images obtained using the single image acquisition protocol”. It is unclear how it is possible to generate a risk assessment on all 4 of these portions of the body with a single portion of an image.
Claims 2-7 and 9-21 depend from claim 1 and inherit the 35 USC deficiencies of their parent claim.
Claim 21 provides for an artificial intelligence algorithm with no clear support in the specification as to how the algorithm operates. It is found to be indefinite as it is unclear what sort of process the algorithm utilizes to generate the risk assessments from the data or what the data includes of the patient.
Allowable Subject Matter
Claims 1-7 and 9-21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance: Applicant’s arguments (pages 4-6) with regard to the combination of different prior art diagnostic techniques into a single concurrent assessment of risk of coronary artery disease, aortic disease, pulmonary embolism, and pneumonia from a single image acquisition protocol is not taught by any of the references and a combination of all of the references would not be obvious as they utilize different protocols and methods of risk assessment then the claimed invention is persuasive.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keith Raymond whose telephone number is (571)270-1790. The examiner can normally be reached Monday-Friday 9AM - 5PM.
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/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798